The following data is part of a premarket notification filed by Igel Vision Care Pte Ltd. with the FDA for Igel(r) 56 (hefilcon C) Soft (hydrophlic) Contact Lens.
| Device ID | K974837 |
| 510k Number | K974837 |
| Device Name: | IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | IGEL VISION CARE PTE LTD. 203 N. WABASH, STE 1200 Chicago,, IL 60601 |
| Contact | John M Szabocsik |
| Correspondent | John M Szabocsik IGEL VISION CARE PTE LTD. 203 N. WABASH, STE 1200 Chicago,, IL 60601 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-24 |
| Decision Date | 1998-07-06 |
| Summary: | summary |